1.28 External Investigator Assurance

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for initiating an External Investigator Assurance (XIA) (also referred to as a “Collaborating Institutional Investigator Agreement”).


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Requirements for, and Content of, an External Investigator Agreement (XIA)


DOCUMENT HISTORY:

 Written: 1/12/2018 (Approved: 1/12/2018) - original author not recorded (previous policy #3.14)

 Revised: 2/6/2018 - revision not documented

 Revision 12/3/2022 - Clarified that XIA is synonymous with “Collaborating Institutional Investigator Agreement”; revised definition of XI to include an investigator who is “not faculty, employee or student of the Organization, and who is not under the jurisdiction of another IRB which has an IRB Reliance Agreement with UNMC”; clarified that an XIA is required for an XI conducting research at any site (including sites operated by the Organization), not just an external site; revised definitions for clarity; provided definition of “external site”; clarified that XIA is required between the Organization and the external site when an external site is engaged in research under a UNMC IRB approved research protocol for which there is not an IRB reliance agreement in place between UNMC and the site. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified - 12/29/2022


Revision #6
Created 21 October 2019 21:53:37 by Autumn M Eberly
Updated 6 January 2023 20:04:56 by Robert A Lewis